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临床试验/NCT06873620
NCT06873620已完成不适用

Impact of the Cardiopulmonary Bypass and Cross-Clamp Time Ratio on Postoperative Outcomes in Open Heart Surgery: A Prospective Observational Analysis

Ahmet Yuksek1 个研究点 分布在 1 个国家目标入组 348 人开始时间: 2024年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
348
试验地点
1
主要终点
Relationship between CPB/CC time and mortality

研究概览

简要总结

This study aims to investigate the relationship between the ratio of cardiopulmonary bypass (CPB) time to cross-clamp (CC) time and postoperative complications in open heart surgery. While CPB time and CC duration have been linked to complications, no study has explored the specific ratio between CPB time and CC time in relation to postoperative outcomes. This prospective study seeks to fill that gap.

详细描述

Open heart surgery involves several distinct stages: 1) preparation for cardiopulmonary bypass (CPB), 2) the CPB phase, which includes the cross-clamp (CC) process, and 3) hemostasis and closure. During the CPB phase, the left internal mammary artery (LIMA) and saphenous vein are freed for coronary anastomosis, followed by arterial and venous cannulation. Once cannulation is completed, CPB is initiated. A cross-clamp is placed on the aorta to stop the heart, and cardioplegia solution is administered. Afterward, distal anastomoses are performed, and once completed, the cross-clamp is removed and the heart begins to beat again. The duration the cross-clamp remains in place is referred to as the CC time. In the CPB phase, proximal anastomoses are made on the aorta. After checking for any bleeding, thoracic drains are placed, and the CPB is terminated. Once all controls are in place, the chest is closed, and the patient is transferred to the intensive care unit.

The mortality rate for open heart surgery varies between 1% and 5%, depending on the patient's specific characteristics. Postoperative complications such as bleeding revision, acute kidney injury, liver failure, respiratory failure, and heart failure are common. Literature has linked these complications to vascular conditions, CPB time, and the duration of cross-clamp time. However, no studies were found that specifically compare the ratio of CPB time to CC time with postoperative complications.

In this study, we aim to prospectively investigate the relationship between the ratio of CPB time to cross-clamp time and postoperative complications in patients undergoing open heart surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing open heart surgery
  • •Undergo on pump surgery

排除标准

  • •Patients undergoing emergency open heart surgery Patients undergoing open heart surgery on a beating heart

结局指标

主要结局

Relationship between CPB/CC time and mortality

时间窗: From enrollment to the end of treatment at 8 weeks

CPB/CC time is the ratio of cardiopulmonary bypass (CPB) time to cross-clamp (CC) time in patients undergoing on-pump cardiac surgery.

次要结局

未报告次要终点

研究者

发起方
Ahmet Yuksek
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Ahmet Yuksek

Associate Professor

Kocaeli City Hospital

研究点 (1)

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